The UK government has been urged to provide new tax incentives for the pharmaceutical industry to invest in bioscience and take steps to improve the uptake of innovative new medicines, including an independent assessment of the long-term impact of the National Institute for Health and Clinical Excellence (NICE).

The call comes in a new examination of the progress made since the publication in 2003 of Bioscience 2015, a report produced by the BioIndustry Association (BIA)-led Bioscience Innovation and Growth Team (BIGT) chaired by Sir David Cooksey. This had forecast that, by 2015, the UK medical bioscience sector would have secured its position as a global leader, with a core of “large, profitable, world-class companies.”

In 2009, this vision now looks “somewhat overoptimistic,” acknowledges the BIGT’s new report, entitled The Review and Refresh of Bioscience 2015 (BIGTR2). A more pragmatic goal now would be the creation of “a diverse and self-sustaining bioscience sector which supports, on a sustainable basis, high value-added employment, thereby leading to increased wealth creation and improved health in the UK,” it says.

Back in 2003, it could not have been anticipated that investors would become increasingly reluctant to invest in emerging bioscience companies and that the public markets would all but close down, says the report. With the Initial Public Offering (IPO) window now tightly closed, the influx of new companies coming onto the market through flotation has dwindled to zero, it adds.

Meantime, the pharmaceutical industry is facing its own issues, including a patent “cliff” equivalent to $140 billion in sales as several blockbusters come off patient over the next few yeas, and an increasing recognition that it must look to third parties to help replenish its pipeline.

The recommendations made in the report – which Sir David said he hopes have been produced in time for the UK budget in March - include a raft of measures to attract foreign investment into the UK bioscience sector. Among these are: - calling on UK Trade & Investment (UKTI) to use its life science marketing strategy to focus on attracting high-quality overseas firms to list on the London Stock Exchange; - persuading overseas funds to invest in the UK; - helping UK firms to gain investment from foreign funds by holding roadshows for non-UK investors in the UK and aboard; and - extending R&D tax credits not only for bioscience companies but also for big pharmaceutical companies, to encourage them to invest here and to spin out their UK assets to create new companies.

The report also calls for an independent inquiry to assess the long-term impact on NICE on the costs, access to and uptake of medicines in the UK, and to review the way in which NICE values medicines.

Describing NICE as “a mixed blessing,” Sir David says: “the theory behind Health Technology Appraisal (HTA) is good, but the effect has been to delay the introduction of new therapies and shorten patent-protected marketing periods. When you add to this the uncertainty of receiving a positive recommendation from NICE, the result is that fewer drugs are coming to the market and benefiting patients.”

There is also much to be done to align regulatory and NICE activities, the study goes on. The Association of the British Pharmaceutical Industry (ABPI) has reported that, for 29 products going through the centralised European Medicines Agency (EMEA) approval process, NICE appraisal delays represented a loss in their patent-protected lifecycles of just over 30%. Moreover, only 30% of new medicines were given unconditional approval, an outcome that fundamentally worsens the case for investing in biotechs, says the report, which calls on the government to take a leadership role within the European Union (EU) to ensure that revisions to improve the EU Clinical Trials Directive reinforce the UK’s attractiveness as a prime location for trials.

Moreover, despite government action since the publication of Bioscience 2015 in 2003, the adoption of new therapies, drugs and procedures within the National Health Service (NHS) remains “painfully slow,” says the report, and it urges the government to ensure that effective incentives are in place for doctors and Trust managers to maximise patient benefits through timely introduction of new therapies. “The concentration must be on outcomes, not processes alone,” adds Sir David.

Another recommendation is for participation in research to be included in the NHS Operating Framework, with a “specific objective” of doubling the number of patients recruited to clinical trials in NHS Trusts over the next three years.